FDA Fails to Pull Worthless Drugs from Marketplace
October 26th, 2009Via: AP:
The Food and Drug Administration has allowed drugs for cancer and other diseases to stay on the market even when follow-up studies showed they didn’t extend patients’ lives, say congressional investigators.
A report due out Monday from the Government Accountability Office also shows that the FDA has never pulled a drug off the market due to a lack of required follow-up about its actual benefits — even when such information is more than a decade overdue.
When pressed about that policy, agency officials said they have no plans to get more aggressive.
The GAO says the FDA should do more to track whether drugs approved based on preliminary results actually have lived up to their promise.
The FDA responded that the report paints an overly negative picture of its so-called “accelerated approval” program, which is only used to approve drugs for the most serious diseases.
“Millions of patients with serious or life-threatening illnesses have had earlier access to new safe and effective treatments,” thanks to the program, the FDA said in its response to the report.
In 1992, the FDA began speeding up the approval of novel drugs based on so-called surrogate endpoints, or laboratory measures that suggest the drug will make real improvements in patient health. HIV drugs, for example, are cleared based on their virus-lowering power, a predictor of increased survival.
Drugmakers favor the program because it helps them get products to market sooner, without conducting long-term patient studies that can take years and cost hundreds of millions of dollars. A condition of quicker approvals is that drugmakers conduct follow-up studies to show the drug’s benefits actually panned out.
But the GAO report, a copy of which was obtained by The Associated Press, identified several drugs still on the market that never lived up to their initial promise. And in the 16 years that the FDA has used accelerated approval, it has never once pulled a drug off the market due to missing or unimpressive follow-up data.
“FDA has fallen far short of where it should be for patient safety,” said Sen. Charles Grassley, R-Iowa, who requested the investigation.
Of the 144 studies the FDA has required under the program since 1992, 64 percent have been completed and more than one-third are still pending, according to the GAO. Investigators said the FDA does not rigorously track whether companies are making progress on their required studies, although the agency is improving.
FDA officials say they have overhauled their tracking system since the GAO completed its report.
This report is good – but it falls short in the recommendation zone. ” From the article: “The FDA approved AstraZeneca’s lung cancer drug Iressa in 2003 based on early results showing it reduced the size of tumors. But later studies showed the drug did not significantly extend patient lives.
The FDA has left the drug on the market, despite hundreds of reports of a sometimes fatal pneumonia.”
There should be a separate function apart from the FDA that follows up on the efficacy of drugs that the agency approves. A separation of duties.
If we think the FDA is going to criticize itself for drugs that it approves, we are fools. And so is the GAO.